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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT02096250 |
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Date of registration:
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21/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Iron Absorption in Haiti
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Scientific title:
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Iron Absorption From Wheat Flour in Haiti |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02096250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Haiti
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Contacts
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Name:
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Isabelle Aeberli, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ETH Zurich, Switzerland |
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Key inclusion & exclusion criteria
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Mother-child pairs will be recruited!
Inclusion criteria for mothers :
- Women of reproductive age (18 to 45 years)
- Generally healthy
- Consenting to study participation
Exclusion criteria for mothers :
- Pregnancy or lactation
- Weight >65 kg
- Chronic illnesses which may influence iron absorption
- Severe anemia (Hb<10 g/dl)
Inclusion criteria for children:
- Age 4 years +/- 12 months
- Generally healthy
Exclusion criteria for children :
- Severe anemia (Hb<10 g/dl)
- Weight for height < -2 Z scores (wasting)
- Height of age < -2 Z score (stunting)
Furthermore, the following exclusion criteria apply to both mothers and children :
- Chronic illnesses or medication which may influence iron absorption (will be judged
by investigator)
- Consumption of vitamin or mineral supplement (unless they agree to discontinue using
them two weeks before beginning of the study until the las visit)
- Allergies or intolerances relevant to the test meal (gluten)
- Blood donation or major blood losses during the 2 months prior to the study
- Illness during the 4 weeks prior to the study (will be judged by investigator)
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iron Deficiency
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Intervention(s)
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Other: NaFeEDTA + ferrous fumarate
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Other: Ferrous fumarate
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Other: NaFeEDTA
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Primary Outcome(s)
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Iron absorption
[Time Frame: 14 days after test meal consumption]
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Secondary ID(s)
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EK 2013-N43
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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